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Medical Device Regulation: complete and correct classification (2/3)

Classification according to MDR, Part 2

First of all, it must be checked whether the product in question is a device that falls within the scope of the regulation. For this purpose, the manufacturer usually checks whether one of the definitions mentioned in the text is applicable to his product. If the answer is positive, the process is often terminated at this point. This is wrong. A complete check also includes a "negative check", i.e. the check whether the product in question is possibly excluded from the regulation.

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Positive AND negative check

Both components of the test, i.e. both the "positive check" of the definitions and the "negative check" of the exclusions should be documented with a well-founded justification. This justification should be traceable to the technical properties and the technology of application of the product. It is only complete if it has taken all exclusion criteria into account.

If the product is found to be complying to the definition of a device and not covered by the exclusion criteria, then it can be assumed that the product is within the scope of the Regulation.

This is the basic requirement for the qualification of the product.

The same mistake is often made in a similar way when applying the classification rules. A rule appears to be suitable for the product, so it is applied and the product is classified accordingly.

Application of the strictest rule

Just like the MDD, however, the MDR also requires the application of the strictest rule. This means that if several rules are applicable to the product, the rule that results in the highest risk class must be applied. Conversely, it also follows that only if all rules have been checked for their applicability can it be determined with certainty which rules would be applicable, and thus the strictest rule can be safely applied.

As with the examination of the scope of application, it is therefore necessary to examine and document the applicability and also the non-applicability of all rules with justification. Likewise, these justifications should show a reference to both the underlying technology of the product and its intended purpose.

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